Oct 30, 2002
By Toni Clarke
The US Food and Drug Administration has told Biogen Inc. to stop publishing misleading promotions for its multiple sclerosis drug Avonex.
In a letter dated October 24 and posted on its Web site on Wednesday, the regulatory agency listed several examples of promotions to physicians and patients that it said violate federal regulations.
Examples of the violations include a headline in a promotional brochure to doctors and patients stating that "Avonex delivers the highest rate of satisfaction -- 95% among patients," followed by a bar graph that the FDA says misrepresents the results of the survey. That's because of the 75 patients surveyed, only 60% said they were "very satisfied" with Avonex while 35% said they were "only somewhat satisfied."
"The omission of these details is misleading to the reader," the FDA's letter said. "You should immediately cease any further dissemination of all advertising and promotional materials that contain these claims and similar presentations."
The company said it had responded to the agency. "We're in conversation with the FDA on this," said Tim Hunt, a Biogen spokesman. "We'll work with the FDA to ensure they're happy."
The FDA admonition comes amid an increasingly fierce battle for dominance in the $1.3 billion US market for multiple sclerosis treatments. Avonex, which is Biogen's only marketed product, was once by far the biggest-selling drug for the disease. Now its market share has slipped to just over 50%.
In March, Europe's Serono SA launched a rival product, Rebif, which is making steady inroads into Biogen's territory. In response, Biogen, based in Cambridge, Massachusetts, has increased its marketing budget and become more aggressive in defending Avonex.
Shortly after Rebif's launch, Biogen appealed to the FDA to prevent Serono from claiming Rebif is superior to Avonex. Biogen said the FDA had agreed to "take enforcement action" if Serono made broad claims of superiority.
But the FDA denied Biogen's statement. Dan Troy, the agency's legal counsel, said through a spokeswoman that he was "not happy" about Biogen's public exploitation of a private phone conversation with the company.
In its latest complaint, the FDA also took issue with the company's promotional statements that "Cognitive dysfunction is significantly correlated with brain atrophy," something that Biogen's clinical trials of the drug did not evaluate.
The agency also criticized, among other statements, the company's exhortation
to doctors to "Prescribe Therapy That is Strong Over The Long Term" with
the subsequent statements "2 years, 4 years, and 5 years" implies efficacy
beyond that approved in the drug's label.
© 2002 Reuters Ltd